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Data and Safety Monitoring Plans (DSMP)

Description

    Data and Safety Monitoring Plans (DSMP) are meant to assure that each clinical investigation has a system for appropriate oversight and monitoring of the conduct of the clinical investigation. This oversight ensures the safety of the participants and the validity and integrity of the data.

    A DSMP is commensurate with the risks involved with the investigation. The DSMP can be as simple as the investigator annually submitting his/her safety and AE information to the IRB or as complex as having a Data and Safety Monitoring Board.

    NIH now requires a Data Safety and Monitoring Plan (DSMP) be submitted with all proposals using human subjects. Funding is being held for investigators who have not submitted a DSMP. In most cases, a proposal submitted without a DSMP will not even be considered. A copy of the DSMP must also be submitted to the UW Human Subjects Office. Contact the Office of Sponsored Programs (osp@u.washington.edu) for more details.

References